Quality & Company
Making essential biologics more accessible
Founded in 2026, SysGene Biologics is guided by a simple belief: essential biologics should be more accessible and affordable. We bring together biologics expertise, enabling manufacturing technologies and focused bioprocess solutions to help manufacturers address production challenges, improve efficiency and reduce costs while maintaining quality. Through products, development support and partnerships, we aim to help high-quality biologics reach more markets.
Our principles
Principles that guide how we work
SysGene is guided by a clear purpose and a responsible, evidence-led approach to developing technologies, products and partnerships.
Mission
To assist patient populations through our clients, in improving access to essential products, through cost reductions utilising our platforms enabling faster, more efficient and scalable approaches to development and manufacturing of drug substances.
Vision
Through scientific rigor, collaboration and transparency to become a trusted development, scale up and manufacturing partner or technology-transfer partner for key GMP & non-GMP molecules for biologic entities and peptides.
Quality
We strive to achieve safe, compliant and reliable development and manufacturing services, through continuous improvement, regulatory excellence, data integrity, with our GMP standards based on ICH Q10 guidelines. Our aim is to enable our clients to bring life-changing therapies to patients worldwide.
Environmental responsibility
We are committed to minimizing the environmental impact of our operations through responsible use of energy, water and raw materials, prevention of pollution, reduction of waste and greenhouse gas emissions, compliance with applicable environmental regulations, and continuous improvement of our environmental performance.
Ethical business practices
We are committed to operating our business through Codes of Conduct, which comply with applicable laws and regulations, respecting human rights, protecting confidential information, and maintaining integrity and transparency throughout every partnership.
Health & Safety
At SysGene the health, safety, and wellbeing of our employees, contractors, visitors, customers, and the communities in which we operate are fundamental to our success. We are committed to maintaining a safe, healthy, and sustainable working environment across all development, manufacturing, laboratory, and support operations.
Quality standards
The guidelines and grades we work to
Quality is built into how SysGene develops processes, characterizes molecules and supplies products.
ICH-aligned development
Development, characterization and analytical activities are aligned with the International Council for Harmonisation (ICH) guidelines for biotechnological products, including ICH Q6B (specifications and characterization), ICH Q5E (comparability) and ICH Q2(R2) (validation of analytical procedures). Our GMP standards are based on ICH Q10.
Product grades
SysGene products are manufactured to the requirements of their stated grade, research grade, multi-compendial or GMP. The applicable grade and its supporting documentation are confirmed for each product.
Multi-compendial standards
Multi-compendial products are specified against the relevant monographs of more than one pharmacopoeia, such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.) and Japanese Pharmacopoeia (JP).
Documented evidence
Technical information is classified as a validated specification, representative result, development target or external benchmark, so the strength of each claim is clear.
Leadership
The team behind SysGene
Manufacturing capability
Capacity in Hyderabad
SysGene operates in-house mammalian bioreactor capacity at 5 L scale and microbial fermenters from development scale to 30 L, 100 L, and 1,000 L in Hyderabad, with 5,000 L capacity planned. Programs may be scoped for GMP or non-GMP manufacture, subject to facility, product and regulatory fit. Additional capacity and specialized capabilities may be delivered through qualified partners.
Discuss a partnership
Tell us about the programme or product requirement and we will route your enquiry to the right team.
Contact SysGene